Cryme Trainer (moved)
Questionable Diagnosis and Treatment
|Ixodes scapularis is the most common tick vector in the northeastern and miswestern U.S. The picture shows (from left to right) the nymph, adult male, and adult female. The spot on the thumb shows the relative size of the nymph.||
Lyme disease typically begins with a skin rash called erythema
migrans (EM), often accompanied by flu-like symptoms of fever,
malaise, fatigue, and muscle and joint pains. The characteristic
skin lesion where the bite occurs is a flat or raised red area
that expands, often with clearing at the center, to a diameter
of up to 20 inches. However, it does not always occur, which can
make the diagnosis more difficult, especially when the patient
is not aware of having been bitten by a tick. Other early signs
can include small skin lesions, facial nerve paralysis, lymphocytic
meningitis, and heart-rhythm disturbances. Early cases are usually
cured by three weeks of orally administered treatment with a common
antibiotic (amoxicillin or doxycycline). However, if untreated
or inadequately treated, neurologic, cardiac, or joint abnormalities
may follow. Worldwide, Lyme disease has probably been directly
responsible for fewer than two dozen deaths .
The disease is named after the town of Old Lyme, Connecticut, where researchers recognized its nature in 1975. In Europe, associations between tick bites and several skin diseases had been known for decades, but it was not understood that various conditions were part of a single illness. Since its nature was clarified, Lyme disease has emerged as a significant source of public controversy . Some people claim to be persistently infected with B. burgdorferi and suffering from debilitating symptoms as a result. Many infectious agents can cause chronic infections or can be difficult to eradicate with standard antibiotic treatments. Unfortunately, it is frequently difficult to diagnose such infections and, in the case of Lyme disease, it is especially difficult to know what percentage of cases persist in the form of chronic infections. Other possibilities for persistent symptoms include: autoimmune-like reactions in which the body attacks its own organs and tissues, physically damaged or scarred organs and tissues from an earlier infection, or another tick-borne infection such as babesiosis or ehrlichiosis.
Of course, symptoms occurring long after the onset of Lyme disease can also be coincidental. A recently published long-term study of 212 Connecticut residents suspected of having Lyme disease found that their incidence of pain, fatigue, and difficulty with daily activities was similar to those 212 age-matched controls without Lyme disease . As noted in an accompanying editorial:
After a median follow-up of 51 months, patients with a diagnosis of Lyme disease that met the national surveillance case definition developed by the Centers for Disease Control and Prevention (CDC) had the same profile of symptoms and the same quality-of-life indicators as age-matched controls without Lyme disease. Thus, recognition and treatment of clear-cut Lyme disease resulted in a return to baseline with no measurable sequelae. On the other hand, patients who were reported to have Lyme disease but who did not meet the CDC's case definition of Lyme disease had increased symptoms and worsening quality-of-life indicators. The implication is that many of these individuals really did not have Lyme disease and therefore did not respond to the treatment .
Limitations of Laboratory Tests
The diagnosis of Lyme disease should be based primarily on an evaluation of the patient's symptoms and the probability of exposure to the Lyme spirochete. Laboratory evaluation is appropriate for patients who have the arthritic, neurologic, or cardiac symptoms associated with Lyme disease, but it is not warranted in patients who have nonspecific symptoms, such as those of chronic fatigue syndrome or fibromyalgia . As aptly summarized by Matthew J. Rusk, MD, and Stephen J. Gluckman, MD, of the University of Pennsylvania:
A true-positive test result consists of a positive enzyme-linked immunosorbant assay [ELISA] or immunofluorescent assay [ILA] followed by a positive Western blot. However, positive results do not prove that [the] patient has Lyme disease and have little predictive value in the absence of characteristic symptoms .
The FDA agrees with the above two paragraphs and has outlined a two-step algorithm for laboratory testing . In a 1997 FDA Public Health Advisory, it advised physicians that:
The results of commonly marketed assays for detecting antibody to Borrelia burgdorferi (anti Bb) . . . may be easily misinterpreted. . . .
Although package inserts for some commercial assays describe their intended use "to aid in the diagnosis of Lyme disease," this statement does not fully reflect current knowledge . . . and many such assays yield potentially misleading results. . . .
Assays for anti-Bb frequently yield false-positive results because of cross-reactive antibodies associated with autoimmune diseases or from infection with other spirochetes, rickettsia, ehrlichia, or other bacteria such as Helicobacter pylori .
One laboratory offered a one-step Lyme Antigen Urine Test [LUAT], data for which were presented at Lyme advocacy meetings and published in the journal of a Lyme advocacy group. However, LUAT systems return a high rate of false-positive results and have been discredited .
In February 1999, the FDA approved the PreVue B. burgdorferi Antibody Detection Assay, an "in-office" test that provides results within an hour. The results are similar in accuracy to those of the ELISA test and must be confirmed with a Western blot test done by a laboratory. In May 2001, the FDA approved another ELISA test called C6.. Produced by Immunetics, Inc., of Cambridge, Massachusetts, it is the first diagnostic tool to use a synthetic product called C6, a hybrid marker based on components derived from the surface of B. Burgdorferi. The C6 test is sensitive only to antibodies generated during an active infection. Both tests should facilitate accurate diagnosis and reduce the number of chronic or problematic cases through early antibiotic treatment.
Some practitioners are inappropropriately diagnosing Lyme disease
in many of the patients who consult them and are administering
one or more of the inappropriate treatments described below.
Malariotherapy and ICHT
Malaria is a parasitic disease that typically involves bouts of fever reaching 40°C to 41°C (104°F to 106°F). Before the antibiotic era, patients in the late stages of syphilis were sometimes given malaria with the hope that the fever would kill the spirochetes responsible for the syphilis. The practice was never subjected to controlled studies and was abandoned decades ago when antibiotics became widely available. In recent years, many Lyme patients have allowed themselves to be injected with blood containing a malaria parasite, Plasmodium vivax . Persons seeking such treatments usually had to travel to Mexico. However, in one case, a Texas resident acquired P. vivax-contaminated blood from an unknown source, injected himself, then treated himself with the antimalarial drug chloroquine . There is no evidence that malaria infection cures Lyme disease (or any other disease for that matter). Moreover, patients who receive malaria-containing blood face significant risks of serious illness or death caused by the malaria itself, a transfusion reaction, or an infection by other pathogens that might be in the blood. All things considered, malariotherapy is far more dangerous than Lyme disease.
Another form of fever therapy administered to patients alleged to have chronic Lyme disease is "intracellular hyperthermia therapy (ICHT)," in which a substance such as 2,4-dinitrophenol (DNP) is administered. According to a proponent Web site:
The net result of ICHT uncoupler therapy causes the mitochondria to be converted from efficient "powerhouses" of energy production to "chemical furnaces", heating cells from the "inside-out." The Lyme spirochetes are subjected to such an amount of heat over a prescribed time that they cannot survive. In essence, ICHT maybe considered a form of therapeutic "pasteurization."
Unfortunately, DNP is a metabolic poison that can result in severe weight loss and even death .
High-pressure (hyperbaric) oxygen is legitimately used to treat
deep sea divers suffering from decompression sickness ("the
bends") and smoke inhalation, and to help treat several other
conditions . There are 300 hyperbaric facilities in the United
States. Some of these facilities have been used to treat AIDS,
chronic fatigue syndrome, and Lyme disease. The Lyme patients
subjecting themselves to long hours in these small chambers apparently
hope that high-pressure oxygen will enhance oxygen-dependent immune
mechanisms and kill spirochetes lurking beyond the reach of antibiotics.
Is HBOT effective against Lyme disease? At far as I know, it has not been subjected to clinical testing for that purpose. One Lyme patient who reported on the Internet said, "After 30 hours of therapy [at $4,000] in 90-minute doses I had no positive results for chronic Lyme treatment." Another online patient wrote, "The director of the clinic is refusing to refund . . . me. This money was for some of the dives I was scheduled to take, but was unable to because I was sick." At best, HBOT is an experimental treatment for Lyme disease. At worst, it is a big waste of time and money.
Many colloidal silver and silver salt preparations have been touted as cures for AIDS, chronic fatigue, herpes, TB, syphilis, lupus, malaria, plague, acne, impetigo, and many other diseases. Lyme disease is just the latest target. A 1996 Federal Register notice declared that the "FDA is not aware of any substantial scientific evidence that supports the use of . . . colloidal silver ingredients or silver salts for these disease conditions." The same notice stated that "human consumption of silver may result in argyria -- a permanent ashen-gray or blue discoloration of the skin, conjunctiva, and internal organs" . Despite these warnings, some Web sites devoted to Lyme disease or colloidal silver products display reports of laboratory experiments in which colloidal silver killed spirochetes. One is a letter from Dr. Burgdorfer, written on National Institutes of Health (NIH) stationary. The letter merely reports on a pilot study using colloidal silver to kill spirochetes in a test tube and states that additional laboratory and human studies are underway. Many silver and Lyme advocates have used the letter to suggest that colloidal silver has been proven effective against Lyme disease. However, no study has shown that colloidal silver is safe or effective for treating people with Lyme disease (or anything else).
Many Lyme disease activists and patients assert that Lyme disease is a difficult-to-treat, chronic infection that requires long-term consumption of broad-spectrum antibiotics. (See common beliefs about Lyme disease.) Although medical practice and clinical trials suggest otherwise , many Lyme patients undergo long-term intravenous antibiotic treatment. For appropriate intravenous antibiotic treatment, the American College of Physicians recommends 21-28 days and various European guidelines call for 10-30 days for the commonly used drugs. Much longer usage has been reported among patients who have Lyme disease as well as patients who have been inappropriately diagnosed [16-18].
Outpatient intravenous therapy is a multi-billion-a-year business.
It remains largely unregulated and can cost patients thousands
of dollars per week. Price-gouging, drug markups, kickbacks, and
self-referral of patients by physicians with financial ties to
infusion companies have occurred. In 1995, for example, Caremark,
Inc., pled guilty to mail fraud charges for entering into illegal
contracts with physicians by paying them to refer Medicaid patients
to use Caremark's infusion products. The settlement provided for
approximately $44.5 million in civil penalties and restitution
from Caremark . In Michigan, prosecutors charged a physician
and Caremark employees with scheming to overbill Blue Cross/Blue
Shield for drugs and equipment for patients with Lyme disease
The intravenous antibiotic therapy administered to Lyme patients sometimes has disastrous results. During the early 1990s, the CDC described 25 cases of antibiotic-associated biliary complications among persons with suspected disseminated Lyme disease . All patients had received intravenous ceftriaxone (Rocephin) for an average of 28 days for suspected Lyme disease. (Ceftriaxone can form precipitates in the presence of bile salts. The resulting "sludge" can block the bile duct.) Twelve patients subsequently developed gallstones. Fourteen underwent cholecystectomy to correct bile blockage. Twenty-two developed catheter-associated bloodstream infections. Yet most of the patients lacked documented evidence of disseminated Lyme disease or even antibodies to B. burgdorferi. In 2000, physicians reported the death of a 30-year-old woman who died from an infected intravenous set-up that had been left in place for more than two years. She was being treated for "chronic Lyme disease" that was unsubstantiated .
The risks and costs associated with such treatments were analyzed in a 1993 report whose authors concluded that most patients with a positive Lyme antibody titer whose only symptoms are fatigue or nonspecific muscle pains, the risks and costs of intravenous antibiotic therapy exceed the benefits .
In an Internet newsgroup post, a woman described being on intravenous Rocephin for 4 weeks, developing gallstones, and switching to another antibiotic regimen for three weeks. She also mentioned a sudden high fever, anemia, low white cell count, systemic pain, heart rhythm disturbance, and neurologic symptoms. Such descriptions are common among devout Lyme patients and provide an unsettling view into the desperate and dangerous measures some people will take to treat suspected Lyme disease. The woman ended her account by writing she had switched her medication to ciprofloxacin. This drug is potent but should not be used unnecessarily. Its adverse reactions include acute psychosis and other neuropsychiatric reactions .
Another patient said he was treated at a Mexican clinic where the doctor admitted that he and his staff knew little about Lyme disease. The patient wrote, "I started on IV Rocephin (two grams a day), and later added oral azithromycin. My symptoms did improved, but I soon hit a treatment plateau. We then tried IV doxycycline, but this made me sick to my stomach." He goes on to describe a long list of other drugs (IV Claforan, Cefobid/Unisyn, Premaxin, a second round of Cefobid/Uisyn, and IV Zithromax), followed by bouts of "severe diarrhea" and phlebitis. Three months and some $25,000 later, DMSO was added to another infusion of Zithromax.
A number of these so-called "Lyme-Literate Medical Doctors (LLMD) have been investigated by their state bord for their extensive use of powerful intravenous antibiotics and other unconventional practices.
Such practices are likely to draw even greater scrutiny with the recent publication of the results of two clinical trials on chronic Lyme disease. The investigators noted "in these two trials, treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo." 
Many patients who believe they have chronic Lyme disease are
willing to endure considerable discomfort in their effort to get
rid of their symptoms. This behavior is fostered by the misguided
belief that antibiotic therapies are not working unless they make
the patient feel worse. These patients typically refer to this
condition as "herxing," a colloquial term for the Jarisch-Herxheimer
(J-H) reaction. This reaction is an acute response thought to
be caused by a sudden release of allergy-causing or toxic substances
when certain organisms (most notably the spirochete that causes
syphilis) are attacked with antibiotics.
About 10% of patients treated for early Lyme disease experience a J-H reaction involving chills, fever, muscle pains, rapid heartbeat, and slight lowering of blood pressure during the first 24 hours of antibiotic therapy. These usually last for several hours, and require little more than aspirin and bed rest. Yet many Lyme newsgroup participants write about a "herx" beginning days or weeks after the start of antibiotic therapy, and "herxing" for weeks at a time -- often in a cyclic fashion." Herxing" events have even been likened to an "exorcism" that is "a necessary evil to be endured." Some of these patients are likely to be suffering from the side effects of their inappropriately prescribed antibiotics. It is also safe to assume that the mistaken belief that Lyme treatment involves temporary worsening will lead some people to neglect other illnesses. Neurological symptoms, blurred vision, gastrointestinal upset, vomiting, and palpitations, for example, should be reported to a physician, not posted on the Internet with a request for comments.
Fear, ignorance and Internet rumors have also created an environment for expanding the mythology of Lyme's protean properties far beyond scientific fact or medical observation. For example, a recent spat of Internet postings has suggested that Lyme can be acquired through sexual contact.
"I think that Lyme is also a STD [sexual-transmitted disease]," said one newsgroup poster. Another wrote, "I've talked to many couples who claim they transmitted to each other through sexual contact. I believe I gave it to my wife."
At least one "Lyme specialist" appears to be telling patients that Lyme is sexually transmitted and therefore their family members should be tested. One person reported to Quackwatch that a family member had been tested and told that the test was positive and that a 4-5 month course of antibiotics was necessary.
There is no basis for such advice. The infection is acquired from the bite of an infected tick. People are "dead end" hosts and do not spread Lyme infections to others.
The topic of pregnancy and Lyme is also rife with rumor and unnecessary fear. During a quarter of a century of research and surveillance, there have been no documented cases of mother-child transmission and no cases of fetal injury associated with a Lyme infection. Recent attempts to demonstrate venereal, transplacental and contact transmission of Lyme spirochetes in hamsters have also failed . In contrast, a case of perinatal transmission of human granulocytic ehrlichiosis (HGE) was reported in the New England Journal of Medicine . Like B. burgdorferi, HGE is transmitted by the Ixodes tick, and simultaneous infections with both have been reported.
The fact that Lyme disease is usually curable has not discouraged
the formation of over a hundred support groups and nonprofit foundations,
some with financial backing from intravenous services hoping to
promote further long-term antibiotic therapies . These groups
and their ardent followers have used the Internet and other media
to barrage politicians and the general public with misinformation,
dire personal stories, rumors, and exaggerated claims about thousands
of people being maimed, killed and bankrupted each year by Lyme
disease. The core message is that Lyme is a deadly chronic disease
that requires long-term antibiotic therapy paid for by insurance
companies. Despite its alleged frequency, NIH-funded clinical
trials in Boston and Bethesda were hampered by a lack of patients
who met science-based criteria for chronic Lyme disease. A third
trial underway at Columbia
University has had to modify its patient entry criteria in
order to find enough patients to carry out the study.
Support groups and individual patients have created many Web sites that contain unsubstantiated assertions, inaccurate medical information, and personal testimonies for the dubious treatments described above. Indeed, the Internet has provided a powerful mechanism for organizing patients and presenting poorly documented information to the public and the press.
Internet newsgroups have posted wild criticisms of physicians and researchers who disagree with their claims and concerns. Research reports that run counter to the claims of Lyme activists are denounced and their authors accused of incompetence and financial conflicts of interest. Magazines and news organizations whose stories on Lyme disease are not sufficiently hysterical are barraged with e-mail complaints and urged to contact certain organizations for "the truth." Protests have been organized to denounce Yale University's research meetings and Lyme clinic because, according to the protesters, Yale "ridicules people with Lyme disease, presents misleading information, minimizes the severity of the illness, endorses inadequate, outdated treatment protocols, excludes opposing viewpoints, and ignores conflicts of interest." Researchers have been harassed, threatened, and stalked . A petition circulated on the Web called for changes in the way the disease is routinely treated and the way insurance companies cover those treatments. Less radical groups have had their meetings invaded and disrupted by militant Lyme protesters.
Some Lyme organizations have tried to raise funds for their own research on hyperbaric oxygen treatments, pregnancy-related Lyme, and a clinical trial of chronic Lyme patients. Others have organized "scientific" meetings that include anecdotal reports by physicians friendly to their cause, and one group has launched a journal that reflects its leaders' beliefs.
The Lyme Disease Buyers Club markets vitamin and nutrient supplements (e.g., flax seed oil, evening primrose oil, coenzyme Q10, garlic, B-complex) to Lyme patients. Its web site states that these nutrients are not a cure but "provide daily support for the body's natural metabolic activities." The club offers "a 10 percent discount off Pro Health's already low, every day catalog prices." and states that "10 percent of each sale will go to Lyme disease research and advocacy projects." However, the initial proceeds went to the Lyme Alliance, of Concord, Michigan, an advocacy group that filed an amicus brief supporting a court appeal by a Joseph Natole, Jr., M.D., whose state medical board had sanctioned him for inappropriately managing patients with actual or suspected Lyme disease. According to a report on the Alliance's Web site: the court ruled against the doctor; his license was suspended for three months; he was fined $50,000; and he was subsequently indicted on federal charges of overbilling insurance companies. The Alliance later circulated a petition stating that, "Lyme disease can and does exist as a chronic illness with persisting infection, and that the disease is greatly underdiagnosed and undertreated." The petition demanded that, "Physicians who are on the front lines of Lyme disease patient care not be harassed, persecuted or made to fear for their medical practices because they do not adhere to the conservative "short term" care for Lyme disease."
A Lyme Vaccine
After a decade of research and pressure from patient advocates and Congress , the FDA licensed the first vaccine for Lyme borreliosis on December 21, 1998. The vaccine, called Lymerix, was derived from a recombinant version of the OspA lipoprotein of B. burgdorferi. Lymerix was intended for "at-risk" individuals between the ages of 15 and 70 years. Given in three separate injections and an annual booster, the vaccine appeared to be effective in preventing infections.
Yet, after years of pre-license clinical trials and three years of commercial sales, the manufacturer, GlaxoSmithKline, pulled the vaccine off the market on February 26, 2002. Glaxo cited poor sales and a projected market this year of less than 10,000 people  as the basis for their decision to end production and distribution of Lymerix. The suddenly demise of Lymerix may give other vaccine manufacturers pause in considering the development of future vaccines against infections that readily respond to common antibiotic therapies, have little associated morbidity, and almost no associated mortality.
Ironically, many of the original advocates for a vaccine turned against Lymerix as soon as it hit the market. Citing its less than perfect efficacy and anecdotal evidence of vaccine-induced arthritis and other injuries, they crowded FDA hearings with tales of personal injury, flooded the Internet with anti-vaccine tautologies, and jointed lawsuits seeking compensation from Glaxo and Pasteur Mérieux Connaught, the maker of a second, but never licensed vaccine .
Despite the lawsuits and the web site tales of personal anguish, repeated studies have failed to find any evidence of specific adverse events associated with Lymerix. Neal Halsey, who helped monitor the first vaccine trial, said, an "active, aggressive search for patients who developed arthritis" after vaccination found no evidence of increased arthritis risk . A CDC study published in the February 2002 issue of Vaccine also failed to detect any "unexpected or unusual patterns" of adverse reactions to vaccination . Reports of adverse reactions to Lymerix, and other vaccines, can be searched for on the Vaccine Adverse Event Reporting System (VAERS) Web site.
As another tick season approaches, it is interesting to note the results of a recent survey of parental attitudes toward Lymerix . The survey authors found that respondents in Nassau County, New York indicated they would "definitely" (23%) or be 'likely" to (65%) request Lymerix for their children. The positive response to Lymerix may be due to the fact that most survey respondents got their information about Lyme disease and the vaccine from a friend or an advertisement (49% and 44%, respectively). The Internet was not identified as a source of information. Yet, the survey found that most respondents were "surprisingly misinformed" about Lyme infections. For example, they considered Lyme infections to be a chronic, difficult-to-treat disease. "Chronic Lyme disease" is a term favored by support groups and patient advocates, but has no basis in medical fact or practice . The endless public repetition of this misleading mantra may have influenced parental opinions in favor of vaccination as a prevention to a chronic infection that does not exist. That option ceased to exist on February 26, 2002.
Despite the Internet noise, fundraising letters from activists, and high-ticket lawsuits, it is not difficult to find accurate information about Lyme disease. Most state health departments provide free brochures or direct online information. Good sources include: